Amlodipine 5 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER Amlodipine 5 mg and 10 mg Tablets (Amlodipine besilate)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Amlodipine Tablets are and what they are used for
2. Before you take Amlodipine Tablets
3. How to take Amlodipine Tablets
4. Possible side effects
5. How to store Amlodipine Tablets
6. Further information.
1. WHAT AMLODIPINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Amlodipine 5 mg or 10 mg Tablets. Amlodipine tablets contain the active ingredient amlodipine (as besilate).
Amlodipine belongs to a group of medicines called calcium channel blockers (calcium antagonists).
Your doctor has prescribed Amlodipine to treat: high blood pressure (hypertension)
angina (severe pain in the chest which may travel into the jaw, neck and arms) including Printzmetal's (or variant) angina.
In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, amlodipine works by improving blood supply to the heart muscle, which then receives more oxygen and, as a result, chest pain is prevented.
Amlodipine tablet does not provide immediate relief of chest pain from angina.
2. BEFORE YOU TAKE AMLODIPINE TABLETS Do not take Amlodipine Tablets if you
are allergic (hypersensitive) to amlodipine besilate, other dihydropyridine calcium antagonists, e.g. felodipine, nifedipine or nicardipine or any of the other ingredients of amlodipine tablets
have had a shock to the body which could include cardiogenic shock (this is the term used when blood pressure becomes so low that your heart stops working properly and medical treatment is required) have a narrowed heart valve (e.g. aortic valve narrowing)
have unstable angina (chest pain which may occur when you are resting excluding Printzmetal's angina), are pregnant and breast feeding
Take special care with Amlodipine Tablets
You should inform your doctor if you have or have had any of the following conditions: recent heart attack (within the last month) severe increase in blood pressure (Hypertensive crisis) liver disease.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you go into hospital, let the medical staff know you are taking Amlodipine.
Taking Amlodipine Tablets with food and drink
Amlodipine is not affected by food; it can be taken before, during or after a meal.
Pregnancy
If you think you might be pregnant, or are planning to get pregnant, tell your doctor before you take amlodipine. Women of child bearing potential should ensure that they use effective contraception.
Breast-feeding
You should not take Amlodipine if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine is unlikely to affect your ability to drive or use machines.
3. HOW TO TAKE AMLODIPINE TABLETS
Always take Amlodipine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take your tablets as follows:
once a day, at the same time each day swallow them whole with a glass of water tablets must not be chewed or crushed.
Adults including elderly
The usual starting dose of Amlodipine Tablets is 5 mg once a day The maximum daily dose of Amlodipine Tablets is 10 mg once a day.
Children and Adolescents
Amlodipine Tablets are not recommended for children under 18 years of age.
If you take more Amlodipine Tablets than you should
Contact your doctor. In the case of an overdose, contact the nearest hospital casualty department immediately. Take this leaflet and any remaining tablets with you.
If you forget to take Amlodipine Tablets
It is important to take amlodipine tablets as directed by your physician. Do not take a double dose to make up for a forgotten dose. If you are worried, ask your doctor or pharmacist for advice.
If you stop taking Amlodipine Tablets
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you. x
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Amlodipine Tablets can cause side effects although not everybody gets them.
If you experience the following side effects while taking your medicine, you should stop taking your tablets and tell your doctor straight away or go to the casualty department of your nearest hospital.
swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in breathing itching, reddening or scaling of the skin appearance of large wheals on the skin heart attack.
The other observed side effects are:
Common side effects (affecting up to 1 in 10 people)
headache and facial flushing (especially at the beginning of treatment)
palpitations
chest pain
feeling sick, stomach ache or pain, indigestion feeling tired, having no energy, dizziness.
Uncommon side effects (affecting less than 1 in 100 people)
if you have heart problems these may seem worse at the beginning of treatment enlargement of breasts in men
fainting, changes in taste, tremors (shaking), loss of sensitivity to touch or pain, tingling or numbness of the hands or feet and increased sweating
sight disturbances
problems sleeping, mood changes
buzzing, hissing, whistling, ringing or other persistent noise in the ears
chest pain
low blood pressure
shortness of breath or nasal irritation (rhinitis) vomiting, diarrhoea, constipation, indigestion, dry mouth
rash, itching, unusual bleeding or bruising under the skin, allergic skin reactions or skin discolouration, hair loss
back pain, muscle or joint pain
increased need to urinate (pass water) particularly at night
impotence (inability to obtain an erection)
feeling unwell, unusual tiredness or weakness
change in body weight.
Very rare side effects (affecting less than 1 in 10,000 people)
isolated cases of severe allergic reactions (described above) severe skin reaction heart attack
unusual heart beat, dangerously fast heart beat decreased platelets which may cause bruishing or nosebleeds, swelling and bleeding of the gums liver problems
high liver enzymeas detected by a blood test
inflammation of the liver (hepatitis)
yellowing of the skin or whites of the eyes (jaundice)
high levels of sugar in your blood (hyperglycaemia) that may make you feel thirsty or need to urinate more often numbness in the fingers and toes purple spotting on the skin (vasculitis) cough
inflammation of the stomach
pancreatitis causing stomach or back pain, nausea, sickness fever or a rapid pulse.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE AMLODIPINE TABLETS
Keep out of the reach and sight of children.
Do not use Amlodipine Tablets after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month. Store below 30°C. Keep the blister in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
The active substance is Amlodipine (added as besilate).
The other ingredients of the tablet are microcrystalline cellulose, Calcium hydrogen phosphate dihydrate, sodium starch glycollate, colloidal anhydrous silica and magnesium stearate.
The tablets are available in two strengths. Each Amlodipine tablet contains either 5 milligrams or 10 milligrams of amlodipine added as amlodipine besilate.
Each 5mg tablet contains 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine Each 10mg tablet contains 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine
This leaflet does not contain the complete information on Amlodipine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
What Amlodipine Tablets look like and contents of the pack
Amlodipine Tablets are presented in a blister pack of 28 tablets and come in 2 strengths.
Amlodipine 5 mg Tablets are white to off white, round, tablets with “5” debossed on one side and plain on the other side.
Amlodipine 10 mg Tablets are white to off white, round, tablets with “10” debossed on one side and plain on the other side.
Marketing Authorisation Holder
APTIL Pharma Limited, 9th floor, C.P. House, 97-107 Uxbridge Road, Ealing, London W5 5TL Manufacturer
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, C.P. House, 97-107 Uxbridge Road, Ealing, London W5 5TL
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